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Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02275299
Recruitment Status : Unknown
Verified October 2014 by Jiangsu Simcere Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
First Posted : October 27, 2014
Last Update Posted : October 27, 2014
Sponsor:
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.

Brief Summary:
This study is intended to evaluate the efficacy and safety of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in patients with active Rheumatoid Arthritis (RA).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Iguratimod Drug: Leflunomide Drug: Methotrexate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod or Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
Study Start Date : September 2013
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016

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Arm Intervention/treatment
Experimental: Iguratimod and MTX combination
Drug:Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid) Drug:MTX 2.5 mg/tablet, taken orally once a week, 4 tablets/week
Drug: Iguratimod
Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks
Other Name: Iremod

Drug: Methotrexate
Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week,52 weeks

Active Comparator: Leflunomide and MTX combination
Drug: Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid) Drug: Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week
Drug: Leflunomide
Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks

Drug: Methotrexate
Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week,52 weeks




Primary Outcome Measures :
  1. Percentage of patients with ACR 20 response and Change in Disease Activity as measured by the DAS28 [ Time Frame: week 52 ]

Secondary Outcome Measures :
  1. Change from baseline in modified Total Sharp Score (mTSS) [ Time Frame: week 52 ]
  2. Percentage of patients with ACR 50 response and ACR70 response [ Time Frame: week 24,week 52 ]
  3. Change from baseline in number of swollen and tender joins, Erythrocyte sedimentation rate (ESR) ,C-reactive protein (CRP),anti-citrullinated-protein antibody (ACPA) and heumatoid factor(RF) [ Time Frame: week 24, week 52 ]
  4. Time to achieve the ACR20, ACR50 and ACR70 [ Time Frame: week 12, week 24, week 40, week 52 ]
  5. Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3 and change from baseline in Health Assessment Questionnaire (HAQ) [ Time Frame: week 12, week 24, week 40, week 52 ]
  6. Incidence of adverse events [ Time Frame: up to 52 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a diagnosis of RA according to the diagnostic criteria of the American College of Rheumatology (ACR) (revised in 1987)
  • Rheumatoid Arthritis for more than 3 months from the time of the initial diagnosis
  • Functional Class II-III
  • Subjects have active RA at the time of screening
  • Subjects with inadequate response to biologics should have a washout period before the initiation of study. For etanercept, washout period should be 2-week, and 8-week for infliximab and adalimumab.
  • For firstly diagnostic RA patients, the disease activity should be moderate to severe, with DAS28>3.2
  • Must have at least 4 tender joints (66 join count) and 8 swollen joints( 68 join count) at screening and baseline
  • Has a C-reactive protein ≥ 10 mg/L(or 1.0 mg/dL) OR Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/hr
  • Must have a negative Pregnancy test and use adequate method of contraception throughout the trial
  • Written informed consent

Exclusion Criteria:

  • Preceding treatment with DMARDs, immunosuppressants (cyclophosphamide, cyclosporine, azathioprine, etc.), or Tripterygium within 4 weeks prior to study entry
  • Subjects have been treated with iguratimod or leflunomide combined with MTX before screening.
  • Subjects combined with other autoimmune disease, such as systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleriasis and polymyositis, except for Sjögren syndrome.
  • Chest x-ray abnormalities, such as tuberculosis, interstitial pulmonary fibrosis, etc.
  • ALT >1.5×ULN, AST >1.5×ULN, Cr >135umol/L, total bilirubin>1.5×ULN
  • WBC<4×109/L,HGB<85g/L,PLT<100×109/L
  • Subjects with serious cardiovascular, renal, hematologic, endocrine diseases or malignant
  • Women of Pregnant or breastfeeding, and male or female with recent plan to conception
  • Subjects with immunodeficiency, uncontrolled infection and active gastrointestinal disease
  • Allergic to any of the study drugs
  • History of alcoholism
  • Subjects with mental illness
  • Subjects receiving live vaccines recently
  • Subjects participating in other clinical study within 3 months prior to study entry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275299


Contacts
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Contact: weihong zhao, doctor +86(25) 8556 6666 ext 8701 zhaoweihong@simcere.com

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100032
Contact: Fengchun Zhang, doctor    +86(10)6915 6114    zhangfccra@yahoo.com.cn   
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.

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Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02275299     History of Changes
Other Study ID Numbers: Tranmod
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: October 27, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Leflunomide
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors